IRadimed Announces 510K Clearance of the New Non-Magnetic MRidium(TM) MRI IV Pump...

IRadimed Announces 510K Clearance of the New Non-Magnetic MRidium(TM) MRI IV
Pump with Integrated Masimo SET(R) SpO2 Monitoring

WINTER PARK, Fla., Aug. 17 /PRNewswire/ -- The United States Food and Drug
Administration has granted IRadimed Corporation clearance of its new MRidium
3860+ MRI Infusion System with integrated Masimo SET(R) SpO2 Monitoring.
Transport to the MRI for Sedation, Critical Care, and Cardiac Patients to date
has required multiple pieces of equipment, with hospital infusion pumps and
SpO2 being typically not designed to be integrated and functional in the MRI.
Clinicians no longer have to remember each time when they get to the door of
the MRI to remove their standard hospital SpO2 equipment so that it does not
become a dangerous projectile, or risk a patient burn, in the MR environment.
IRadimed has innovatively combined two critically needed technologies for the
MRI to increase productivity, patient safety, and ease of transport to, from,
and within the MRI.

The Innovative MRidium(TM) 3860+ MRI Infusion System is the first Non-Magnetic
IV Pump designed specifically for use in the MRI Environment with Integrated
Masimo SET(R) technology. "We chose the Masimo SET(R) technology because it
has such an excellent reputation in the marketplace. Masimo's systems are
viewed by most as one of the best monitoring technologies in the world," said
Todd Weber, VP Sales and Marketing. Safety in the MR is the primary concern
when it comes to meeting needs for required patient care. These risks are all
well-known, as essential IV and monitoring equipment can: fly into the bore,
cause artifacts on the images, become unreliable during crucial deliveries of
medications and monitoring, or shut down completely when needed the most. Use
of improper pulse oximeters has caused severe burns to patients due to the
high RF fields involved within MR scanners. "It is critical to have products
which have been designed with the utmost care and thorough insight of this
harsh and potentially dangerous environment," said Roger Susi, founder of
IRadimed Corporation.

In hospitals all around the globe, the patient population going to the MRI is
growing every day. Today, more and more hospitals are eliminating the long IV
lines under their MR Scanner Room doors. Recent studies indicate the addition
of 15 to 30 feet of IV Extension Sets significantly reduces the alarm times of
syringe and IV pumps, making delivery of critical medications risky at best.
Patients are coming to MRI with more IV lines and new types of cases, such as
stressing the heart, inter-operative procedures, brain lab suites, cancer
patients, and sedations, with many of these patients needing accurate delivery
at lower rates and volumes. The MRidium(TM) System has been designed to meet
these changing needs by reducing the risk; there is no need for long IV lines
or Syringe pumps placed outside the Magnet Room. No need to remember to remove
the standard hospital SpO2 Monitor, because the MRidium(TM) Pump has the
ability to maneuver right next to the bore of the MRI and deliver medications
safely and efficiently. All while being monitored through its wireless remote
control, which operates inside the MRI control room.

The MRidium(TM) Pump has the ability to work at the 10,000 Gauss magnetic
field environment of 1.5 and 3.0 Tesla MR Scanners, and the system includes
the remote control ability for adjusting critical medication deliveries and
alarm monitoring from outside the MR Scanner room. The safe placement of the
pump is of the utmost importance, because these safety-critical Gauss line
limits are invisible and different for every magnet design and strength, which
makes it difficult to know where the safe limits are in relation to the MR
Scanner. The 10,000 Gauss Line is virtually inside the bore of the MR Scanner
in many cases, which allows the use of the MRidium(TM) Pump in close proximity
to the MR scanner.

The MRidium(TM) System's remote ability allows clinicians to monitor the
infusion progress and make changes to the pump from outside the MR scanner
room without having to stop the scan; this provides the ability to adjust or
bolus critical medications, such as Propofol, which is commonly used for MR
Anesthesia, without interrupting, or unnecessarily delaying, the MR scan.

The New MRidium(TM) 3860+ System has a number of key new features which make
this MR IV Pump simple and safe to deliver even the smallest of infusions.
With rate ranges from 0.1 ml to 1400 ml per hour, the MRidium(TM) System is
designed to meet all of your infusion needs. The new 10-digit keypad makes
programming a snap, with quick changes at the press of a few buttons. This
Smart Infusion System also has an integrated programmable drug library
designed for the MRI - making it an indispensable tool for delivery of
critical medications such as Dobutamine, Adenosine, Propofol, and
Dexmedetomidine. The system also offers a modular second channel which allows
for delivery of two medications simultaneously during patient scans. A range
of available infusion sets provides the necessary clinical flexibility needed
for MRI Infusion. The MRidium(TM) 1055 Bypass Infusion set allows clinicians
to quickly change over IV sets from the hospital-based infusion system without
having to disconnect the lines from the patient. The MRidium(TM) 1057 Vented
Syringe Adapter Set allows for accurate delivery from a syringe using a low
priming volume of only 4 milliliters per set.

The MRidium(TM) 3860+ MRI IV Pump with Integrated Masimo SET(R) SpO2
Technology is marketed globally through one of their many distributors. To
request a demonstration, please contact sales@iradimed.com or call:
1-407-677-8022 and ask for the sales department.

About IRadimed Corporation

IRadimed Corporation has vast experience in MRI safe products and Infusion
Therapy. Our founder is the pioneering developer of the world's first and
best-selling MRI-compatible monitoring system. Our staff has a combined 60+
years developing MRI-safe products. The MRidium(TM) Infusion System has full
benefit of the experience and attention to details so important to the
development of quality equipment which can be safely used in the MRI setting.

http://www.iradimed.com

MRidium(TM) is a Trademark of IRadimed Corporation

Masimo(R) and Masimo SET(R) are registered trademarks of Masimo Corporation.

Contact:

Todd Weber
Vice President Sales and Marketing
IRadimed Corporation
407-677-8022 Ext. 112
tweber@iradimed.com

This release was issued through eReleases(TM). For more information, visit
http://www.ereleases.com.

SOURCE IRadimed Corporation

Todd Weber, Vice President Sales and Marketing of IRadimed Corporation,
+1-407-677-8022 Ext. 112, tweber@iradimed.com